- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07706881
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Although the female body and fetus are physiologically equipped to carry out the birthing process, the increasing medical interventions in the birthing process today are pushing women into the background during labor. This situation can indirectly affect the duration of labor by causing an increase in women's anxiety and perceived pain levels. In this regard, the application of non-pharmacological methods that support women in effectively managing pain, enabling their active participation in childbirth, shortening the duration of the stages of labor, and having low cost and side effects, stands out as an important care option for women. Today, the use of non-pharmacological methods by midwives who play an active role in childbirth and postpartum care is becoming increasingly common. Among the non-pharmacological approaches are distraction techniques; Practices such as deep breathing exercises, early skin-to-skin contact, listening to relaxing music, watching videos, virtual reality applications, communicating, or cognitive focus shifting contribute to a woman's perception of her birthing experience as more controllable and comfortable .
This research will be conducted to evaluate the effect of music listening and stress ball application on placental separation time, pain during episiotomy repair, and breastfeeding success in primiparous pregnant women.
Study Overview
Status
Intervention / Treatment
Detailed Description
Although the female body and fetus are physiologically equipped to carry out the birthing process, the increasing medical interventions in the birthing process today are relegating women to the background during labor. This situation can indirectly affect the duration of labor by causing an increase in women's anxiety and perceived pain levels. In this context, the application of non-pharmacological methods that support women in effectively managing pain, enabling their active participation in childbirth, shortening the duration of the stages of labor, and having low cost and side effects, stands out as an important care option for women.
Non-pharmacological methods, which play a significant role in supporting woman-centered childbirth care, not only contribute to pain management but also help improve maternal and neonatal outcomes by supporting the physiological progress of labor . The placental phase, the third stage of labor, is a process that begins with the birth of the fetus and ends with the separation and expulsion of the placenta and its appendages from the uterus, generally encompassing the first 5-30 minutes following delivery . It has been reported that non-pharmacological methods used in labor contribute to the more orderly progression of physiological processes by reducing the mother's pain and stress levels. Distraction and relaxation-based practices such as mother-baby skin-to-skin contact, listening to music, and stress balls can support the mother's relaxation and positively influence neurohormonal responses; in particular, by increasing oxytocin release, they can support the effectiveness of uterine contractions and contribute to facilitating the placental separation process. In addition, increased oxytocin release is important for initiating early lactation and supporting milk production. In their study, Farisoğlu et al. (2019) stated that the placental separation process after vaginal delivery without any intervention is between 10-15 minutes. Literature shows that this time can be shortened using non-pharmacological methods. In a study published by Gündüz and Öztürk in 2023, skin-to-skin contact applied during the third stage of labor resulted in a placental separation time of 7.05 minutes in the experimental group and 13.41 minutes in the control group, and it was found to increase breastfeeding success. In Karaman's 2017 study, the time to placental separation during delivery was found to be 16.57 minutes in the study group and 21.00 minutes in the control group .
One of the interventions performed during labor is an episiotomy. An episiotomy is a procedure involving the surgical widening of the perineal tissue to facilitate fetal delivery during the second stage of labor. A significant consequence of episiotomy is pain. Pain and stress responses can negatively impact breastfeeding by suppressing oxytocin, a hormone that plays a key role in milk production and release. Therefore, effective pain management is crucial for maintaining the mother's psychological well-being, strengthening the mother-infant bond, and initiating breastfeeding early. While commonly used to reduce pain and anxiety during episiotomy repair, lidocaine-derived local anesthetics, sedatives, and hypnotics are reported to have some side effects on both maternal and neonatal health. The use of these medications can lead to undesirable conditions such as changes in fetal heart rate, hypothermia, hypotonia, respiratory depression or apnea in the newborn, and hypotension in the mother . Therefore, in current obstetric care, there is a growing interest in non-pharmacological methods during episiotomy repair that have a low risk of side effects, increase maternal comfort, and support pain management, in addition to pharmacological methods.
In a study by Baradwan et al., it was found that early skin-to-skin contact during episiotomy significantly reduced pain scores during episiotomy repair. A study by Gökduman Keleş, using virtual reality glasses with music, found that perceived pain levels were lower during episiotomy repair. Reducing pain and anxiety during childbirth lowers levels of stress hormones such as cortisol and catecholamines, supporting oxytocin release; this physiological process contributes to the regulation of uterine contractions and increased maternal relaxation. Oxytocin plays a critical role not only in the physiological progression of childbirth but also in initiating and maintaining breastfeeding in the postpartum period. By activating the milk let-down reflex, it facilitates the transfer of breast milk to the baby; it also contributes to relaxation, reduced stress levels in the mother, and strengthening the mother-baby bond. Therefore, it is thought that non-pharmacological practices that support oxytocin release during childbirth can positively contribute not only to improving the birthing experience but also to the early initiation and maintenance of breastfeeding by reducing maternal stress and pain levels. Since breastfeeding is a fundamental care practice in protecting and improving maternal and newborn health, these methods are reported to play an important role in supporting breastfeeding success.
Music is one of the methods frequently used today as a complementary therapy for physical, mental, and surgical procedures. Studies have shown promising results in reducing anxiety and stress levels in mothers and improving fetal parameters (such as heart rate variability). Furthermore, music therapy positively affects the mother's lactation process. Studies supporting this exist in the literature. Studies by Kır (2020) and Soyer (2017) concluded that listening to music such as white noise and lullabies positively influenced breastfeeding.
Stress balls are a simple and effective distraction method during painful procedures. Virtual reality, music therapy, and stress ball applications used to distract patients undergoing outpatient gynecological procedures have been effective in reducing anxiety and pain and increasing patient satisfaction. Another study examining the effect of stress ball use on individuals' pain, anxiety, and satisfaction levels reported that participants who used stress balls had lower pain and anxiety levels and significantly higher satisfaction levels.
The use of non-pharmacological methods applied by midwives in childbirth and postpartum care is becoming increasingly common today. These methods include distraction techniques such as deep breathing exercises, early skin-to-skin contact, listening to relaxing music, watching videos, virtual reality applications, and cognitive focus shifting, which contribute to a woman's perception of the birth experience as more controlled and comfortable.
Although it has been reported that listening to music that provides auditory relaxation and using a stress ball, a distraction-based method, are effective in reducing stress and pain perception, evidence regarding the outcomes of these methods in the third stage of labor is limited. While there are studies in the literature examining the effects of music on pain and breastfeeding, no research has been found that evaluates its effect on the time to placental separation. Similarly, although stress ball application has been studied in different areas such as endoscopy, prostate biopsy, nail surgery, and pain and comfort management during the active phase of labor, a study evaluating its effects on placental separation time, perceived pain during episiotomy repair, and breastfeeding success has not been found. Therefore, a combined evaluation of the effects of music therapy and stress ball applications on placental separation time, episiotomy pain, and breastfeeding success will fill a significant gap in the literature and contribute to the development of evidence-based care practices for the third stage of labor. Furthermore, it is expected that the findings will support the safe separation of the placenta within the physiological process, increase maternal comfort, strengthen breastfeeding success, reduce the need for pharmacological analgesia, and contribute to the dissemination of woman-centered childbirth care by encouraging the integration of low-cost, easily applicable interventions that can be implemented under midwife-led leadership into clinical practice. This research; This study will be conducted to evaluate the effects of music therapy and stress ball application on placental separation time, pain during episiotomy repair, and breastfeeding success in primiparous pregnant women.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research assistant Ayşegül Şahin Çelebi
- Phone Number: +905524047952
- Email: ascelebi@beu.edu.tr
Study Locations
-
-
Bitlis
-
Bitlis, Bitlis, Turkey (Türkiye)
- Bitlis Eren University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 and over,
- The pregnant woman must be at term (37-42 weeks),
- Primiparous,
- Singleton pregnancy,
- Vertex presentation,
- Vaginal delivery,
- Mediolateral episiotomy,
- Healthy newborn
Exclusion Criteria:
- Bleeding requiring intervention,
- Lacerations other than episiotomy (anal sphincter injury or 3rd or 4th degree tear),
- Interventional labor (with vacuum or forceps),
- Use of anesthesia other than local anesthesia (5 ml lidocaine) before and during episiotomy repair,
- High-risk pregnancy,
- Any complications in the mother or baby,
- Placental separation not spontaneous and removal by intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music performance group
Before any procedure is performed, an informed consent form and a pregnancy identification form will be administered. When the baby is born and the cord is clamped, music will be played. When the baby is born and the cord is clamped, a stopwatch will be started. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the music will be terminated, and breastfeeding success will be evaluated with the LATCH Breastfeeding Assessment Scale. |
Music will be played during the procedure.
|
|
Experimental: stress ball application
Before any procedure is performed, an informed consent form and a pregnancy profile form will be administered. A stress ball application will be performed when the baby is born and the cord is clamped. A stopwatch will be started when the baby is born and the cord is clamped. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the application (stress ball) will be terminated, and breastfeeding success will be evaluated with the LATCH Lactation Assessment Scale. |
The stress ball will be squeezed during the procedure.
|
|
Experimental: both music listening and stress ball application.
Before any procedure is performed, an informed consent form and a pregnancy profile form will be administered. When the baby is born and the cord is clamped, both music and stress ball application will be performed. A stopwatch will be started when the baby is born and the cord is clamped. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the application (music, stress ball) will be terminated, and breastfeeding success will be evaluated with the LATCH Breastfeeding Assessment Scale. |
During the procedure, both music will be played and a stress ball will be squeezed.
|
|
No Intervention: no intervention
Before any procedure is performed, an informed consent form and a pregnancy profile form will be administered. A stopwatch will be started when the baby is born and the cord is clamped. The time it takes for the placenta to separate will be monitored with the stopwatch. The time of placental delivery will be noted in the relevant section of the form. The mother will be given a "VAS pain score" before, during, and after the episiotomy repair. After all procedures are completed, the mother's breastfeeding success will be evaluated using the LATCH Lactation Assessment Scale. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Placental Separation Time
Time Frame: During the third stage of labor
|
Placental separation time will be measured in minutes using a stopwatch from umbilical cord clamping until complete placental expulsion.
|
During the third stage of labor
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity During Episiotomy Repair
Time Frame: Before, during, and immediately after episiotomy repair.
|
Pain intensity will be assessed using the Visual Analog Scale (VAS) before, during, and after episiotomy repair.
|
Before, during, and immediately after episiotomy repair.
|
|
Breastfeeding Success
Time Frame: Within the first postpartum hour after birth.
|
Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool.
|
Within the first postpartum hour after birth.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ayşegül şahin çelebi, not connected
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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